Randomized, multicenter, parallel, open, phase 4 study to compare the efficacy and safety of rosuvastatin/amlodipine polypill versus atorvastatin/amlodipine polypill in hypertension patient with dyslipidemia.

Abstract

The authors performed this study to investigate the efficacy and safety of a rosuvastatin (RSV)/amlodipine (AML) polypill compared with those of atorvastatin (ATV)/AML polypill. We included 259 patients from 21 institutions in Korea. Patients were randomly assigned to 1 of 3 treatment groups: RSV 10mg/AML 5mg, RSV 20mg/AML 5mg, or ATV 20mg /AML 5mg. The primary endpoint was the efficacy of the RSV 10.20mg/AML 5mg via percentage changes in LDL-C after 8weeks of treatment, compared with the ATV 20mg /AML 5mg. There was a significant difference in the mean percentage change of LDL-C at 8weeks between the RSV 10mg/AML 5mg and the ATV 20mg/AML 5mg (full analysis set [FAS]: -7.08%, 95% CI: -11.79 to -2.38, p=.0034, per-protocol analysis set [PPS]: -6.97%, 95% CI: -11.76 to -2.19, p=.0046). Also, there was a significant difference in the mean percentage change of LDL-C at 8weeks between the RSV 20mg/AML 5mg and the ATV 20mg/AML 5mg (FAS: -10.13%, 95% CI: -15.41 to -4.84, p=.0002, PPS: -10.96%, 95% CI: -15.98 to -5.93, p<.0001). There was no significant difference in the adverse events rates between RSV 10mg/AML 5mg, RSV 20mg/AML 5mg, and ATV 20mg/AML 5mg. In conclusion, while maintaining safety, RSV 10mg/AML 5mg and the RSV 20mg/AML 5mg more effectively reduced LDL-C compared with the ATV 20mg /AML 5mg (Clinical trial: NCT03951207).